FDA recall Z-0034-2022

Flower Orthopedics Corporation · Class II · device

Product

Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

Reason for recall

Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)

Distribution

US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL, IN, NC, NY, NV, OH, WV, TX.

Key facts

Status
Terminated
Initiation date
2021-09-03
Report date
2021-10-13
Termination date
2022-07-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0034-2022